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Virtual Reality for Mental Health

N/A
Recruiting
Research Sponsored by Thomas Caruso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1(baseline), day 2
Awards & highlights

Summary

This trial will explore whether VR can improve wellbeing in hospitalized kids compared to traditional care.

Who is the study for?
This trial is for pediatric patients aged 5 to 25 at LPCH/SHC facilities looking to improve their self-efficacy in healthcare settings. It's not suitable for those who are pregnant, clinically unstable, non-consenting, use corrective glasses (incompatible with VR), prone to motion sickness or seizures, or currently nauseous.
What is being tested?
The study is testing whether using Virtual Reality (VR) can boost self-confidence in young patients during healthcare compared to the usual care without VR. Participants will be randomly assigned to receive either the standard of care alone or with an additional educational VR experience.
What are the potential side effects?
While there aren't direct side effects from the intervention itself, participants should be aware that using VR could potentially cause temporary discomfort like dizziness or nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1(baseline), day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1(baseline), day 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in educational self efficacy
Secondary study objectives
Change in current mental well being as measured by the modified WHO (Five) Well-Being Index
Change in the caregiver perception of the educational experience of the patient
Change in the intrinsic motivation
+2 more
Other study objectives
Change in the Positive and Negative Affect feeling and emotion for Children

Trial Design

2Treatment groups
Experimental Treatment
Group I: Virtual Reality then Standard of CareExperimental Treatment2 Interventions
Participants will be randomized to receive the virtual reality intervention on the first day and receive standard of care on the second day of in-patient care.
Group II: Standard of Care then Virtual RealityExperimental Treatment2 Interventions
Participants will be randomized to receive the standard of care on the first day and receive virtual reality intervention on the second day of in-patient care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Reality
2017
Completed Phase 3
~1580
Standard of Care
2017
Completed Phase 4
~4420

Find a Location

Who is running the clinical trial?

Thomas CarusoLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT05725395 — N/A
Mental Health Research Study Groups: Standard of Care then Virtual Reality, Virtual Reality then Standard of Care
Mental Health Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT05725395 — N/A
Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT05725395 — N/A
~0 spots leftby Sep 2024
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